| CTRI Number |
CTRI/2021/07/034981 [Registered on: 19/07/2021] Trial Registered Prospectively |
| Last Modified On: |
15/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Yoga for migraine |
|
Scientific Title of Study
|
Development and validation of integrated yoga therapy module for patients suffering with Migraine. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGirish Baburao Kulkarni |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology
First floor
National Institute of Mental Health and Neuro Sciences Hosur road Bangalore INDIA
Bangalore
KARNATAKA
560 029
India |
| Phone |
08026995752 |
| Fax |
|
| Email |
gbk5000@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Mailankody |
| Designation |
Assistant Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology
First floor
National Institute of Mental Health and Neuro Sciences, An Institute of National Importance (NIMHANS) Hosur road Bangalore INDIA
Bangalore
KARNATAKA
560 029
India |
| Phone |
08026995752 |
| Fax |
|
| Email |
poojakiran2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Assistant Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Integrative Medicine
National Institute of Mental Health and Neuro Sciences
Hosur road Bangalore INDIA
Bangalore
KARNATAKA
560 029
India |
| Phone |
08026995730 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for Research in Yoga and Naturopathy,New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Girish Baburao Kulkarni |
| Address |
Department of Neurology
First floor
NIMHANS
Hosur road
Bangalore INDIA 560 029 |
| Type of Sponsor |
Other [CCRYN Delhi] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGirish |
NIMHANS |
Department of Neurology
First floor
Hosur road
Bangalore
Bangalore
KARNATAKA |
080-26995751
gbk5000@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Yoga therapy |
The yoga therapy will involve different mind-body components including loosening exercises, breathing practices, asanas, pranayama, relaxation and yogic counseling for Migraine. The therapy module will be of 1 hour duration. To be taught for 5 days a week for 1 week (5 supervised sessions). First session will be under direct in-person supervision after that subjects will be taught the same through tele-mode. After initial 5 sessions subjects will continue home practice for another 3 weeks using recorded videos and practice list. So the total duration of intervention is 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
History of headache for more than 6 months
Patients having migraine with or without aura with a frequency of 2 to 8 attacks per month.
Have had migraine for at least 1 year before participating in the study and before the age of 45.
Migraine diagnosis according to The International Classification of Headache Disorders criteria confirmed by a Neurologist.
Willing to follow medical and lifestyle advice
Minimum education with the ability to read and write
|
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with any syndromal psychiatric disorder or suicidality.
Major medical illness under treatment
Women having migraine related to menstruation
Severe headache requiring acute intervention as assessed by the neurologist
Interval headaches not distinguishable from migraine
Medication-overuse headache
Use of daily migraine prophylaxis in the 12 weeks prior to the study
Regular yoga practice past 3 months (three or more times per week prior to the study)
Earlier regular practice of relaxation
Use of any other form of alternative medicine
Any medical comorbidity which is an exclusion for practicing yoga
Pregnancy
Clotting disorders
Breastfeeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop an integrated yoga module for patients with migraine and study its feasibility in this population. |
Baseline, 5 days and 1 month. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Migraine is known to be one of the commonest primary headache disorders affecting 13% of the population worldwide. Although pharmacological interventions have been used to reduce symptoms and frequency of attacks of migraine overuse of these medications may increase headache progression. Failing to achieve optimal control over migraine pain or unacceptable medication side effects might have led to the use of complementary and alternative medicine (CAM) either alone or in combination with drugs. | Although several studies have shown the beneficial effects of yoga therapy in migraines a validated yoga module has not been used. Therefore we propose to develop and validate an integrated yoga module for management and prophylaxis of migraine as an adjunct and study its feasibility and acceptability. Also, we would like to assess if yoga can be practiced along with routine medications. | |